Slow approvals put drug trials industry at risk

SummaryDrugs firms complain that sluggish bureaucracy in New Delhi and a lack of legal clarity.

Slower government approval for testing new medicines is threatening India's aspirations to be a fast-growing, low-cost hub for clinical trials, and has prompted some drugs firms to shift operations elsewhere, adding to their costs.

While India's drug regulator and the health ministry's medical research body deny any slowdown, interviews by with pharmaceutical companies, lobby groups, industry watchers and healthcare activists tell a different story.

Drugs firms complain that sluggish bureaucracy in New Delhi and a lack of legal clarity on how to conduct clinical trials have created a climate of regulatory uncertainty in the market.

That has been exacerbated by a high profile case in the Supreme Court between the regulator and health activists, who allege that companies used poor people as human "guinea pigs" to trial unsafe drugs without their knowledge or consent, and without proper state scrutiny. They have asked the court to suspend all trials for new chemical entities (NCEs) - substances that may be turned into a new drug after tests.

Drugmakers, speaking on condition of anonymity, say the case has made government officials more cautious in considering new approvals, asking more questions and being tougher to convince.

"The situation was never quite easy in India," said Siddhant Khandekar, a healthcare analyst at ICICI Direct brokerage in Mumbai. But with the Supreme Court case "the scenario has worsened and getting new approvals has become more time consuming," he said.

"ANYWHERE IN THE WORLD"

The legal case has prompted Piramal Enterprises Ltd. a $1.8 billion Indian drugmaker, to look abroad to trial new drugs, its vice chairperson Swati Piramal said, warning that India was losing its "innovation edge".

The approval time for initiating drug trials in India typically stretches to 6-8 months, compared to just 28 days in Europe and Canada, said Piramal. "Post the Supreme Court case, certainly companies like us will look anywhere in the world to see if we get good trials," she said.

Lupin Ltd. India's fourth-largest drugmaker by sales, said it had wanted to conduct an NCE trial in India last year, but the $5 billion firm eventually went overseas as the approval process was too slow and made more uncertain by the ongoing Supreme Court case.

"I think the intention is right but the implementation is so slow, that it's hampering in the near term," said Nilesh Gupta, Lupin's group president. "For NCEs in particular in India, the process is extremely long."